HIMSS Immunization Integration Program CDC Modular Test Plan v11

The current IIP test plan includes eight capabilities. Each of these capabilities describes workflow-related concepts that group together common testable actions. The change from prior versions of the IIP test plan provides greater clarity regarding the intent and purpose of each grouping. Current capabilities include:

• Test Preparation – Data Load and PH Configuration
  • Facilities
  • People
  • Vaccine Inventory
  • Public Health Configuration
    
    
• Care Provision and Documentation
  • Select Patients
  • Enter patient provided immunization related information
  • Display patient's updated immunization local system (non-IIS) forecast
  • Enter vaccination order
  • Record vaccines with 2D barcode scanner and manually (no barcode scanner)
  • Produce printable version of patient's immunization record
  • Display a patient’s local immunization forecast after adding vaccine administration events to the immunization history
  • Vaccine dose expiration is visually apparent to administering practitioner
  • Identify and record publicly provided-vaccine program eligibility
  • Record adverse events
  • Inform users of risks due to previous adverse events within the ordering or administering workflows for potential causative agents
  • Record vaccine administration refusal
  • Produce cohort reports
    
    
• Query, Response and Reconciliation
  • Display local forecast
  • Transmit query to the IIS and receive response
  • Compare IIS-provided information
  • Display SUT vaccination history including the user-reconciled IIS-provided history
  • Re-evaluate patient’s immunization forecast
  • Not an exact match response (RSP)
    
    

• Transmission and Acknowledgment

  • Transmit newly recorded immunization records to IIs
  • Receive and process acknowledgement messages
  • Update vaccine record previously submitted to IIS
  • Transmit newly recorded historical immunization record
  • Transmit and delete record and for immunization
  • Transmit refusal for immunization
  • Transmit patient consent (protection status)
    
    
• Patient Access
  • Provide patient or a designated individual electronic access to the patient’s immunization record.
    
    
• Clinical Configuration
  • Add new vaccine codes
  • Update immunization schedule to reflect changes in ACIP recommendations
    
    
• Transport
  • Send and receive immunization messages using the CDC WSDL
    
    
• Data Quality
  • Prevention of critical date data entry errors.

Please use the crosswalk located here: under user documents>HIMSS IIP Test Plan v11.0 Crosswalk

This provides the data that should exist in the system under test before testing scenarios are performed.

Data listed in the test cases listed in this test plan exist in the system under test.

Mother's maiden name is expected to be populated for all minor patient.

Middle names are expected to be populated for all patients.

Middle names for next of kin are expected to be populated for all patients.

Phone number and email (if provided with patient data load) is expected to be populated for all patients.

The SUT SHALL link standard codes (i.e., LOINC for tests or evaluation tools, NDC codes for current immunizations, CVX for historical immunizations, MVX manufacturer codes, VIS codes, and appropriate codes for administration site, route, method, etc.) to discrete data elements associated with an immunization.

This is a non-evaluated test step that must be performed to support other associated steps.

This was an attestation item-previously attested to.

This IIP test plan tests clients with NDC as the primary code set and CVX as an alternate code set. Please note that this configuration may vary among jurisdictions. NDC is required for all new administrations and CVX for historical but can include NDC if known.

This activity is not performed under proctor observation.

This provides the details for facilities that should exist in the system under test before testing scenarios are performed.

Some additional identifiers listed under data entry are only needed for specific tests where additional MSH fields or OIDs are being requested.

SUT Organization/Facility/Assigning Authority Definitions

Sending Application - SUT (Message Header)

Sending Facility - SUT (Message Header)

Patient Identifier Assigning Authority (PID-3)

Practitioner Assigning Authority (ORC-10, ORC-12, RXA-10)

Administered At-Location (RXA-11.4) 

Order Information Assigning Authority Information (ORC)

IIP NIST Tool Organization/Facility/Assigning Authority Definitions

IIP Facility (Receiving Responsible Organization – IIP NIST Tool)

Receiving Application (Message Header)

Receiving Facility (Message Header)

Data listed in the test cases listed below exist in the system under test.

This activity is not performed under proctor observation.

This was an attestation item-previously attested to.

This provides the details for people (patients and providers) that should exist in the system under test before testing scenarios are performed.

Data listed in the test cases listed below exist in the system under test.

This activity is not performed under proctor observation.

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This was an attestation item-previously attested to.

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Functions associated with this patient: 3.1.0, 3.2.0, 3.3.0, 3.4.0, 3.5.0, 3.6.0, 3.7.0, 3.8.0, 3.9.0, 5.1.0, 5.2.0, 5.3.0, 5.4.0

Name abbreviated in Function and Test Step title as: LGD

Please use the Job Aid for all steps associated to this patient that require forecast dates and DOB dates.

The Job Aid can be located here in NIST under Documentation> User Documentation>HIMSS IIP Test Plan v11.0 Job Aid

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Functions associated with this patient: 3.10.0, 3.11.0, 5.7.0

Name abbreviated in Function and Test Step title as: AJM

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Functions associated with this patient: 3.12.0, 3.13.0, 4.1.0, 4.2.0, 4.3.0, 4.4.0, 4.5.0

Name abbreviated in Function and Test Step title as: SNM

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Functions associated with this patient: 3.14.0, 5.5.0, 5.6.0

Name abbreviated in Function and Test Step title as: DCM

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Steps associated with this patient: 4.6.4, 4.6.5, 4.6.6

Name abbreviated in Function and Test Step title as: FMN

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Steps associated with this patient: 4.6.1, 4.6.2, 4.6.3

Name abbreviated in Function and Test Step title as: JJS

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the patient that should exist in the system under test before testing scenarios are performed.

Functions associated with this patient: 7.0.0

Name abbreviated in Function and Test Step title as: FIN

Data listed in this test case exists in the system under test.

Patient Pre-load

The Protection Indicator is the consent to share information with the registry. When marking if the patient has consented or not consented the applicable field, PD1-12 shall be marked with  "Y" =Yes, protect my information (No consent) or "N" =No, do not protect my information (Consent).

This step provides the details for the practitioner that should exist in the system under test before testing scenarios are performed.

Data listed in this test case exists in the system under test.

Practitioner Pre-load

This step provides the details for the practitioner that should exist in the system under test before testing scenarios are performed.

Data listed in this test case exists in the system under test.

Practitioner Pre-load

This provides the details for vaccine products that should exist in the system under test before testing scenarios are performed.

This IIP test plan tests clients with NDC as the primary code set and CVX as an alternate code set. Please note that this configuration may vary among jurisdictions. NDC is required for all new administrations and CVX for historical but can include NDC if known.

Inventory

Unit-of-Use (Vial/Syringe) Image
GTIN	10358160811439
	(01)10358160811439(17)290927(10)IIPVAXN01

Unit-of-Use (Vial/Syringe) Image
GTIN	00300064981018
	(01)00300064981018(17)290927(10)IIPVAXN02

Unit-of-Use (Vial/Syringe) Image
GTIN	10358160821056
	(01)10358160821056(17)290927(10)IIPVAXN03

Unit-of-Use (Vial/Syringe) Image
GTIN	10358160820431
	(01)10358160820431(17)290927(10)IIPVAXN04

Unit-of-Use (Vial/Syringe) Image
GTIN	00349281547584
	(01)00349281547584(17)290927(10)IIPVAXN05

Unit-of-Use (Vial/Syringe) Image
GTIN	10358160740029
	(01)10358160740029(17)290927(10)IIPVAXN07

Unit-of-Use (Vial/Syringe) Image
GTIN	00300064121018
	(01)00300064121018(17)290927(10)IIPVAXN08

Unit-of-Use (Vial/Syringe) Image
GTIN	00300064121018
	(01)00300064121018(17)240326(10)IIPVAXN09

Unit-of-Use (Vial/Syringe) Image
GTIN	10358160811439
	(01)10358160811439(17)290927(10)IIPVAXN10

Unit-of-Use (Vial/Syringe) Image
	(01)10358160825436(17)290927(10)IIPVAXN11
GTIN	10358160825436

Data listed in the test cases listed below exist in the system under test.

This activity is not performed under proctor observation.

If unable to enter expired vaccination product please alert the proctor.

This was an attestation item-previously attested to.

Jurisdictions will individually determine if the Unit of Use or Unit of Sale NDC will be used when submitting vaccines to their IIS. This plan uses the Unit of Use NDC.

See test step for details.

See test step for details. 

The SUT shall be required to capture the respective vaccine program applicable to the vaccine administered.

Various jurisdictions are establishing new programs to provide vaccines and their administration to defined patient populations for some or all vaccines.  Many are jurisdiction-specific programs.  

For context, the Immunization standard 2.5.1 uses OBX-5 to specify the client's eligibility for a funding program and the dose administered level. Table 0064 lists available codes as V01 Not VFC eligible, V02 VFC eligible-Medicaid/Medicaid Managed Care, V03 VFC eligible Uninsured, V04 VFC eligible American Indian/Alaskan Native, VFC eligible-Federally Qualified Health Center (underinsured), V07 Local-specific eligibility. The extension of the Financial Class code set supports local vaccine program eligibility - IIP024- Emergent Tick Borne Illness Vaccine Program

Supports steps 7.1.1, 7.1.2, 7.1.4 and 7.1.5

No existing inventory codes contain a financial class of IIP024

The entered vaccine includes a reference to the specific program that represents HL7 financial class IIP0024

Go to step 3.1.1

To test the ability that the SUT can manage new program eligibility codes as they become available

Add Jurisdiction-Specific Vaccine Eligibility Code: The SUT demonstrates the ability to manage/add new program eligibility codes as they become available and to configure dose-level vaccine eligibility codes per jurisdictional requirements.

Financial class-specific eligibility program IIP024 exists post-entry:

1. Local user adds vaccine program to SUT

OR

2. SUT vendor enters vaccine program for users

If a new vaccine program cannot be added dynamically, it should be added via the process originally attested to prior to the day of testing.
Previously Attested to: (a) Process for adding new program, (b) time it takes to add new program

This "test group" includes basic functionality that allows SUT users to prepare, administer, and record care provision. Advanced functionality is excluded from this capability.

Advanced functionality excluded from the  "Care Provision and Documentation" capability includes: query, response, and reconciliation; display IIS immunization forecast; system configuration; display immunization forecast, transmission and acknowledgment; display immunization history; basic data quality; patient access; configuration; and transport.

See test step for details.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.1.1

Requirement: The SUT allows a practitioner to query and then select a patient's local medical record to perform subsequent actions such as view or update information or initiate a query for information to an IIS.

The user selects Lance Gaige Duncan, Jr as the patient. See HIMSS IIP v11.0 Job Aid for patient DOB, Today (day of test) the patient is 0 years, 1 months, and 17 days old.

Lance Gaige Duncan Jr. is registered in the SUT. Please use the HIMSS IIP Test Plan v11.0 Job Aid located here for all steps related to Lance Gaige Duncan.

Daniela Jennifer Wyatt is the practitioner.

Lance Gaige Duncan Jr. is selected by a user as the active patient in the SUT.

Go to step 3.2.1

That the SUT can select one or more patients from a list of active patients.

This is a non-evaluated test step that must be performed to support other associated steps.

This was an attestation item-previously attested to

.
The following patient is selected as the active patient:

See test step for details.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.2.1

SUT product shall permit the entry of patient-provided immunization information and records its source within local medical record.

Lance Gaige Duncan Jr.'s mother, Ingrid Stacy Duncan, brings a paper copy of the patient's birth hospital vaccine record to Oregon Family Medicine. This includes a birth dose of hepatitis B.

The hospital record does not indicate which hepatitis B vaccine product, therefore, the practitioner entering the vaccine in the patient's record uses CVX code 45 hepatitis B vaccine, unspecified formulation. This CVX code allows reporting of a vaccination when formulation is unknown (for example, when recording a HepB vaccination when noted on a vaccination card).

Lance Gaige Duncan Jr. is registered in the SUT.

Lance Gaige Duncan Jr. is selected by a user as the active patient in the SUT.

Lance Gaige Duncan Jr.'s hospital paper medical record reflects a dose of hepatitis B was received on (see HIMSS IIP Test Plan v11.0 Job Aid for DOB/Administration Date)

Daniela Jennifer Wyatt is the practitioner.

Lance Gaige Duncan Jr.'s SUT record reflects a dose of hepatitis B was received on (Please use the job aid located here: HIMSS IIP Test Plan v11.0 Job Aid). This dose is noted/labeled as 'historical'.

Go to step 5.4.1 to transmit the historical dose from this step.

The SUT must enable entry of an immunization provided elsewhere, i.e., not administered by the practice running the software.

The software must be able to allow a practitioner to directly enter information about an immunization reported by a patient with minimum data requirements including:

(1) name of immunization product

(2) date of immunization (may be at specificity of year; month; and day)

(3) source of information (e.g. from IIS, from another practitioner)

Additionally, the software must store the source data captured and assure it is displayed in the immunization history indicating provenance (the data elements required). The proctor may accept display with an indicator which provides a mouse-over or a hyperlink for users to view all of the provenance details.

SUT product shall Permit the entry of patient-provided immunization information and records its source within local medical record.

User Interface (UI) may only show vaccine product as "hepatitis B vaccine, unspecified formulation" - If the UI does not include the CVX code, the SUT must show how the display is linked to the underlying CVX code 45

Vaccine source must be recorded as "Historical information - from other provider" or a similar local version. This must differ from a historical doses from an unspecified source. In subsequent test steps, RXA-9 SHALL be populated as "02^Historical information - from other provider" no other codes will be accepted.

The hospital paper medical record does not include: the ordering practitioner, administered at facility, administering practitioner, the administered amount, administered units, the vaccine tradename, the vaccine manufacturer, the dose expiration date, the dose lot number, or vaccine route and site. Therefore, these data are not entered into the SUT.

See test step for details.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.3.1

See test step for details.

Lance Gaige Duncan Jr.'s  SUT medical record now includes a hepatitis B vaccine dose record provided by a parent with minimum data.

Lance Gaige Duncan Jr.'s SUT record reflects a dose of hepatitis B was received on (Please use the HIMSS IIP Test Plan v11.0 job aid). This dose is noted/labeled as 'historical'.

Daniela Jennifer Wyatt is the practitioner.

Lance Gaige Duncan historical dose has been entered in the SUT and is visible to users.

Go to step 3.4.1

To test the capability that the SUT is able to display updated immunization history.

Lance Gaige Duncan Jr.'s SUT medical record reflects the following minimum data:

Vaccine source must be recorded as "Historical information - from other provider" or a similar local version. This must differ from a historical doses from an unspecified source. In subsequent test steps, RXA-9 SHALL be populated as "02^Historical information - from other provider" no other codes will be accepted.

See test step for details.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.4.1

See test step for details.

The SUT is able to Display a single patient's immunization forecast report which may be (1) from the IIS - forecast with history of vaccinations this patient has received or (2) display immunization forecast created after reconciliation of IIS data with local data, or (3) in the absence of a new forecast, display the forecast obtained from the IIS (i.e., must display a forecast which SHALL be post-reconciliation if any changes have been made, or the original IIS forecast received if no reconciliation has occurred. 

Two pre-conditions exist:
1.) Lance Gaige Duncan Jr. is registered in the SUT.
2.) Lance Gaige Duncan historical dose has been entered in the SUT and is visible to users.

Daniela Jennifer Wyatt is the practitioner.

Updated forecast is available in SUT

Go to step 3.5.1

To test the capability that the SUT is able to display forecast after immunization record updated.

At a minimum, the patient's forecast shall contain the dates for which the next childhood vaccine dose(s) are due:

Vaccine forecast for: Lance Gaige Duncan Jr.
DOB: Please use the  job aid located here: HIMSS IIP Test Plan v11.0 Job Aid
Age as of today: Today (day of test) the patient is 0 years, 1 months, and 17 days old

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

For proctor: We expect to see a recommended date. If other dates are shown they are not to be evaluated. Take a screen shot of this forecast to compare the forecast generated in 3.9.1.

For this patient who is on schedule, the recommended age is used rather than recommended spacing.

"Recommended" is the date at which the next target dose should be given.

Other vaccines besides those listed above are not to be evaluated.

The SUT supports the ability to enter vaccine orders.

Dr. Ramon Michael Bradshaw is the practitioner.

Go to step 3.5.1

Allow practitioners to order the administration of immunizations to a patient using filters for type of vaccine, including combination vaccines.

Dr. Ramon Michael Bradshaw, orders the four vaccines to be administered to Lance Gaige Duncan Jr.:

The patient Lance Gaige Duncan Jr.is registered in the SUT.

Lance Gaige Duncan Jr. has been selected as the active patient in the SUT.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

An administering practitioner is able to select the same patient selected by Dr. Ramon Michael Bradshaw, the ordering provider, and the patient may now be administered doses of all vaccines ordered.

Go to step 3.6.1

To test the capability that the SUT allows the order of immunizations for a patient using filters for vaccine types, including combination vaccines.

Dr. Ramon Michael Bradshaw intends to look for vaccines containing hepatitis B antigen.

The SUT will allow filtering as shown and the SUT user will enter the orders for the products listed as “The vaccine to be ordered”

Each order may be processed individually, or each selected to create an order set that allows entry of all orders together.

The SUT displays the following list of vaccines containing hepatitis B antigen:

From the above list of vaccines containing hepatitis B antigen Item 1, PEDIARIX, CVX 110 is ordered.

Dr. Ramon Michael Bradshaw uses the information below to order(s) for the patient's first vaccine:

Next, Dr. Ramon Michael Bradshaw intends to look for vaccines containing Hib antigen.
The SUT displays the following vaccine containing Hib antigen:

From the above vaccine containing Hib antigen, ActHIB, CVX 48 is ordered.

Dr. Ramon Michael Bradshaw uses the information above to record order(s) for the patient's second vaccine.

Next, Dr. Ramon Michael Bradshaw intends to look for vaccines containing rotavirus antigen.
The SUT displays the following vaccine containing rotavirus antigen:

From the above containing rotavirus antigen, Rotarix CVX 119 is ordered.

Dr. Ramon Michael Bradshaw uses the information above to record order(s) for the patient's third vaccine.

Next, Dr. Ramon Michael Bradshaw intends to look for vaccines containing Pneumococcal conjugate antigen.
The SUT displays the following vaccine containing Pneumococcal conjugate antigen:

From the above containing Pneumococcal conjugate antigen, Prevnar 20 CVX 216 is ordered.

Dr. Ramon Michael Bradshaw uses the information above to record order(s) for the patient's fourth vaccine.

The proctor may accept one of the following presentations as acceptable for this test step:
(a) The SUT presents a list of all immunizations and provides the user with ability to filter by antigen and the sorted display includes single antigen and combination vaccines containing that antigen. The user selects each of the four vaccines indicated and orders each either as individual steps for each or a single step ordering all four.
(b) The SUT allows selection of each of the four immunizations in the test step directly from an immunization schedule, opening the ordering screen for each as it is selected and displaying only the vaccines containing the respective antigen(s).

Coded values are not expected to be displayed to the user, but it is expected that the value displayed to the user has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions.

Depending on the SUT's configuration, four separate orders may need to be placed, one for each vaccine dose.

In later tests it is expected vaccine products NDCs will appear in RXA segments and the ordering and entering practitioners will appear in a single ORC segment.

The SUT supports the ability to perform immunization data entry by scanning 2D barcodes found on vaccine vials and syringes: vaccine type and manufacturer (found within the NDC which is encoded in the GTIN), expiration date, and lot number.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.6.1

See test case for details

See test case for details

This may be performed concurrently as the function "Record vaccine administration".

The SUT supports the ability to perform immunization data entry by scanning 2D barcodes found on vaccine vials and syringes: vaccine type and manufacturer (found within the NDC which is encoded in the GTIN), expiration date, and lot number.

Based upon the orders of Dr. Ramon Michael Bradshaw, Nurse Daniela Jennifer Wyatt prepares to administer and record vaccines for Lance Gaige Duncan Jr. The following vaccines will be administered AND have 2D barcodes printed upon their vials/syringes: PEDIARIX, Rotarix, and ActHIB. These 2D barcodes are to be scanned to record vaccine type, lot number, and expiration date.

Dr. Ramon Michael Bradshaw, orders the four vaccines to be administered to Lance Gaige Duncan Jr., however only the 3 listed below are scannable. 1 barcode is not scannable for Prevnar 20 and will be manually entered.

The above vaccine products exist in the SUT's inventory.
The SUT is connected to or may access a peripheral (e.g., handheld scanner or camera) that support scanning 2D barcodes printed on vials/syringes.

Daniela Jennifer Wyatt is the administering practitioner.

Lance Gaige Duncan Jr. administered doses with 2D barcodes (PEDIARIX, Rotarix, and ActHIB) have been recorded in the SUT and are visible to SUT users.

Go to step 3.7.1

To test the capability that the SUT is able to scan 2D barcodes for vaccine administrations.

Lance Gaige Duncan Jr. has been administered vaccines by Nurse Daniela Jennifer Wyatt and the following information is entered into the patient record and visible in the SUT:

The 2D Barcode provided information in the following fields should be correct and without omission.

Item 1
Product Name (This may vary with each implementation)	PEDIARIX
Date Administered	Today's date
Unit-of-Use (Syringe or Vial) NDC	58160-0811-43 (for reference only, please scan 2D barcode)
Manufacturer	GlaxoSmithKline (for reference only, please scan 2D barcode)
Lot Number	IIPVAXN01 (for reference only, please scan 2D barcode)
Expiration Date	09/27/2029 (for reference only, please scan 2D barcode)
Dose	0.5mL
Unit-of-Use (Vial/Syringe) Image that shall be scanned.	GTIN 10358160811439
CVX	110
Dose-level Eligibility for Vaccines for Children	American Indian or Alaska Native
Route	INTRAMUSCULAR
Site	Left Vastus Lateralis
VIS Given	Multi Pediatric Vaccines VIS - 07/24/2023
Item 2
Product Name (This may vary with each implementation)	ActHIB
Date Administered	Please use the HIMSS IIP job aid
Unit-of-Use (Syringe or Vial) NDC	49281-0547-58
Manufacturer	sanofi pasteur
Lot Number	IIPVAXN05
Expiration Date	9/27/2029
Dose	0.5mL
Unit-of-Use (Vial/Syringe) Image that may be scanned.	GTIN 00349281547584
CVX	48
Dose-level Eligibility for Vaccines for Children	American Indian or Alaska Native
Route	INTRAMUSCULAR
Site	Right Vastus Lateralis
VIS Given	Haemophilus Influenzae type b (Hib) Vaccine VIS - 08/06/2021
Item 3
Product Name (This may vary with each implementation)	Rotarix
Date Administered	Today's date
Unit-of-Use (Syringe or Vial) NDC	58160-0740-02
Manufacturer	GlaxoSmithKline
Lot Number	IIPVAXN07
Expiration Date	9/27/2029
Dose	1mL
Unit-of-Use (Vial/Syringe) Image that may be scanned.	GTIN 10358160740029
CVX	119
Dose-level Eligibility for Vaccines for Children	American Indian or Alaska Native
Route	ORAL
Site	N/A
VIS Given	Rotavirus Vaccine VIS - 10/15/2021

The VIS encoded value that is associated with the most current VIS for the vaccines and evaluated in the transmit message, can be found in the CDC VIS Lookup Table located here: https://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html

The SUT supports the ability to perform immunization data entry by hand keying in vaccine details found vials and syringes: vaccine type and manufacturer (found within the NDC which is encoded in the GTIN), expiration date, and lot number.

Daniela Jennifer Wyatt is the practitioner.

Go to step 3.7.1

See test case for details

See test case for details

This may be performed concurrently as the function "Scan 2D barcodes found on vaccine vials and syringes to input the vaccine information"

The SUT supports the ability to perform immunization data entry by hand keying in vaccine details found vials and syringes: vaccine type and manufacturer (found within the NDC which is encoded in the GTIN), expiration date, and lot number.

Based upon the orders of Dr. Ramon Michael Bradshaw, Nurse Daniela Jennifer Wyatt prepares to administer and record a dose of Prevnar 20 00005-2000-01, lot number LLBUAYMO6 for Lance Gaige Duncan Jr. However, the 2D barcode printed upon its vial/syringe is smudged and will not scan. Vaccine type, lot number, and expiration date are to be entered without a barcode scanner.

Dr. Ramon Michael Bradshaw, orders the four vaccines to be administered to Lance Gaige Duncan Jr., however 1 barcode is not scannable for Prevnar 20 and will be manually entered.

Prevnar 20, CVX 216

Daniela Jennifer Wyatt is the administering practitioner.

Lance Gaige Duncan Jr. is administered dose without a scannable 2D barcode (Prevnar 20), it has been recorded in the SUT and is visible to SUT users.

Go to step 5.1.1 to transmit vaccines from step 3.6.1 and 3.7.1

To test the ability that the SUT allows for manual entry of data from vaccine UoU.

Lance Gaige Duncan Jr. has been administered vaccines by Nurse Daniela Jennifer Wyatt and the following information is entered into the patient record and visible in the SUT:

The VIS encoded value that is associated with the most current VIS for the vaccines and evaluated in the transmit message, can be found in the CDC VIS Lookup Table located here: https://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html

The SUT produces a printable version a patient's immunization record that can be provided to a patient or caregiver.

Daniela Jennifer Wyatt is the practitioner.

Three pre-conditions have been met:

1) Lance Gaige Duncan historical dose has been entered in the SUT and is visible to users.

2) Lance Gaige Duncan Jr. administered doses with 2D barcodes (PEDIARIX, Rotarix, and ActHIB) have been recorded in the SUT and are visible to SUT users.

3) Lance Gaige Duncan Jr. is administered dose without a scannable 2D barcode (Prevnar 20), it has been recorded in the SUT and is visible to SUT users.

Go to step 3.8.1

See test step for details.

Produces a printable version a patient's immunization record that can be provided to a patient or caregiver.

At the end of the visit for Lance Gaige Duncan Jr. mother, Ingrid Stacy Duncan requests a printed immunization record she can provide to her childcare provider as proof of Lance Gaige Duncan Jr. in-progress vaccine status.

Three pre-conditions have been met:

1) Lance Gaige Duncan historical dose has been entered in the SUT and is visible to users.

2) Lance Gaige Duncan Jr. administered doses with 2D barcodes (PEDIARIX, Rotarix, and ActHIB) have been recorded in the SUT and are visible to SUT users.

3) Lance Gaige Duncan Jr. is administered dose without a scannable 2D barcode (Prevnar 20), it has been recorded in the SUT and is visible to SUT users.

Daniela Jennifer Wyatt is the practitioner.

Ingrid Stacy Duncan is provided a printed copy of the immunization record for Lance Gaige Duncan Jr.

Go to step 3.9.1

To test the capability that The SUT produces a printable version a patient's immunization record that can be provided to a patient or caregiver.

The printed vaccination record includes the following minimum elements: See HIMSS IIP Modular Testing Job Aid for dates

DTaP may be split out into its three components: Diphtheria, Tetanus & Pertussis.

Daniela Jennifer Wyatt is the practitioner.

The SUT display a patient's local immunization forecast, updated after administration of vaccination doses.

Use the Job Aid Link below.

HIMSS IIP Test Plan v11.0 Job Aid

Display a patient's local immunization forecast, updated after administration of vaccination doses.

Three pre-conditions exist: 

1)Lance Gaige Duncan Jr. is registered in the SUT.  

2)Lance Gaige Duncan historical dose has been entered in the SUT and is visible to users. 

3) Lance Gaige Duncan Jr. is administered dose without a scannable 2D barcode (Prevnar 20), it has been recorded in the SUT and is visible to SUT users.

Daniela Jennifer Wyatt is the practitioner.

The pre-condition doses are visible in the SUT and the IIS.

Go to step 3.10.1

To test the capability that the SUT is able to display a patient's local immunization forecast, updated after administration of vaccination doses.

This forecast for DTaP, hepatitis B, Hib, pneumococcal, and rotavirus vaccines shall differ from the forecast displayed before administration in test step 3.4.1

At a minimum, the patient's forecast shall contain the date(s) for which the next childhood vaccine dose(s) are due:

Vaccine forecast for: Lance Gaige Duncan Jr.
Today's Date: Please use the HIMSS IIP Test Plan v11.0 Job Aid
DOB: Today (day of test) the patient is 0 years, 1 months, and 17 days old

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

SUT Informs the practitioner administering a vaccine if the dose chosen for administration is expired.

See test step for details.

Supports 3.10.3 - Informs administering practitioner that vaccine is expired

The user selects Alexandria Jacqueline Montoya (DOB 03/27/2012) as the active patient and opens her record in the SUT.

Alexandria Jacqueline Montoya (DOB 03/27/2012) is registered in the SUT and has indicated No Consent given to share her data with IIS.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

Alexandria Jacqueline Montoya is the active working patient in the SUT.

Go to step 3.10.2

The SUT is able to select a patient for the purpose of entering an order.

This is a non-evaluated test step that must be performed to support other associated steps.

The following patient is selected as the active patient:

This step sets up the testing for notification of expired vaccine. No evaluation is required.

Supports 3.10.3 - Informs administering practitioner that vaccine is expired

Dr. Ramon Michael Bradshaw, orders a dose of GARDASIL 9 (HPV9) for Alexandria Jacqueline Montoya (DOB: 03/27/2012). He is unaware of the current vaccine inventory, vaccine funding or patient vaccination program eligibility status.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

Alexandria Jacqueline Montoya (DOB 03/27/2012) is registered in the SUT.
Alexandria Jacqueline Montoya is the active working patient in the SUT.
Two vaccine items have been entered into the SUT's inventory both for GARDASIL 9 (HPV 9), one is expired (Lot Number IIPVAXN09) and the other (Lot Number IIPVAXN08) is unexpired (i.e., still potent).

The administering practitioner, Daniela Jennifer Wyatt is able to select Alexandria Jacqueline Montoya (DOB: 03/27/2012), the same patient selected by Dr. Ramon Michael Bradshaw, the ordering practitioner, and the patient, Alexandria Jacqueline Montoya (DOB: 03/27/2012) may now be administered a dose of HPV vaccine.

Go to step 3.10.3

To test the ability of the SUT to order a vaccine from a selection of non-expired inventory.

This is a non-evaluated test step that must be performed to support other associated steps.

The following is not evaluated but must occur to evaluate additional SUT functionality in subsequent test steps:

Dr. Ramon Michael Bradshaw, orders a dose of GARDASIL 9 (HPV9) for Alexandria Jacqueline Montoya (DOB: 03/27/2012)

Administering Practitioner Daniela Jennifer Wyatt begins the process of fulfilling Dr. Ramon Michael Bradshaw vaccine order for Alexandria Montoya (DOB: 03/27/2012). Daniela Jennifer reviews the GARDASIL 9 - HPV9 inventory in the SUT.

Daniela Jennifer Wyatt notes two vaccine items are in the clinic's vaccine storage unit, both for GARDASIL 9 - HPV9, one is expired (Lot Number IIPVAXN09) and the other (Lot Number IIPVAXN08) is unexpired (i.e., still potent).

(1) The patient, Alexandria Jacqueline Montoya (DOB 03/27/2012), is registered in the SUT.
(2) Two vaccine items have been entered into the SUT's inventory both for GARDASIL 9 - HPV9, one is expired (Lot Number IIPVAXN09) and the other (Lot Number IIPVAXN08) is unexpired (i.e., still potent).
(3) Dr. Bradshaw has ordered GARDASIL 9 - HPV9 for Alexandria Jacqueline Montoya (DOB 03/27/2012).
(4) Daniela Jennifer Wyatt, the administering practitioner, has opened the SUT's records for Alexandria Jacqueline Montoya (DOB 03/27/2012).

The SUT makes the expired vaccine dose visually apparent from the unexpired doses to the administering practitioner or does not permit the administering practitioner from selecting an expired vaccine dose.

Go to step 3.11.1

To test the capability that the SUT allows the administering practitioner to distinguish between expired and unexpired vaccine doses or prohibits the administering practitioner from selecting an expired vaccine dose.

While selection from a list would allow passive informing of expiration date, bar code scanning only allows active informing. “Active” informing means that the SUT either disallows the entry or allows the entry with information. If disallowed, the user by default must select a different product. If allowed, the user must delete the “incorrect” entry, and proceed to select the different product.

The SUT distinguishes the expired vaccine dose from the unexpired doses and is visually apparent to the administering practitioner. Alternatively, the SUT may prevent expired vaccine doses from being visible or selected by users.

The selection workflow includes clear evidence of a product expiration date in at least one of the following ways (only 1 method is required):

• Passive: The vaccine product with expiration date before today not displayed by the SUT (i.e., cannot be chosen)
• Passive: The display of selectable vaccine products has includes the expiration date and expiration dates before today are displayed with some indication that choosing that product is discouraged (e.g., hover over tooltip, color, bolding, graying out, or other UI indication used by the SUT for similar issues)
• Active: Selection of a specific expired vaccine product to administer generates an informative messages in a method consistent with the SUT for similar issues) - Active informing

Alternatively, the SUT may meet the requirement by prohibiting the selection of an expired dose. However, careful consideration should be made when implementing such a strategy. A recent real-world example was the extension of emergency use authorization (EUA) vaccine product's expiration date by FDA. In systems where a product's expiration date is not able to able to be extended, users may need the option to administer vaccine product that the system believes to be expired.

Daniela Jennifer Wyatt is the practitioner.

See test step for details.

Administering Practitioner Daniela Jennifer Wyatt continues the process of fulfilling Dr. Ramon Michael Bradshaw's vaccine order for Alexandria Montoya (DOB: 03/27/2012).

Daniela Jennifer Wyatt recalls there was only one potent (i.e., not expired) GARDASIL 9 - HPV9 product in the vaccine storage unit (Lot Number IIPVAXN08).

Daniela Jennifer Wyatt notes that lot number IIPVAXN08 for GARDASIL 9 - HPV9 was paid for using Private funds which conflicts with the vaccine program eligibility for Alexandria Montoya (DOB: 03/27/2012), VFC eligible - Medicaid/Medicaid Managed Care

After determining infrequent replenishment is allowed by the State VFC Program and to ensure the patient begins the HPV9 series, Daniela Jennifer Wyatt decides to use lot number IIPVAXN08 for today's visit and replace the privately funded vaccine after the next VFC vaccine order is received.

(1) The patient, Alexandria Jacqueline Montoya (DOB 03/27/2012), is registered in the SUT.

(2) Two vaccine items are stored in the clinic's vaccine storage unit, both for GARDASIL 9 (HPV 9), one is publicly funded and expired (Lot Number IIPVAXN09) and the other (Lot Number IIPVAXN08) is privately funded and unexpired (i.e., still potent).

(3) Dr. Bradshaw has ordered an HPV9 vaccine for Alexandria Jacqueline Montoya (DOB 03/27/2012). in step 3.10.2

(4) Daniela Jennifer Wyatt, the administering practitioner, has opened the SUT's records for Alexandria Jacqueline Montoya (DOB 03/27/2012).

(5) Infrequent replenishment is allowed by the State VFC Program.

The SUT makes the mismatch of the vaccine product's funding source and the patient's vaccine program eligibility visually apparent to the administering practitioner or does not permit the administering practitioner from selecting the mismatched vaccine.

Alexandria Jacqueline Montoya (DOB 03/27/2012) is vaccinated with GARDASIL 9 - HPV9 lot number IIPVAXN08, and this information is incorporated into the SUT.

Go to step 5.7.1 to transmit this vaccine administration.

To test the capability that the SUT allows the administering practitioner be aware of a mismatch of the vaccine product's funding source and the patient's vaccine program eligibility.

The SUT distinguishes the publicly funded vaccine dose from the privately funded doses and is visually apparent to the administering practitioner. Alternatively, the SUT may prevent publicly funded vaccine doses from being visible or selected by users.

The selection workflow includes clear evidence of a vaccine funding source in at least one of the following ways (only 1 method is required):

• Passive: The vaccine product that is privately funded is not displayed by the SUT (i.e., cannot be chosen)
• Passive: The display of selectable vaccine products which includes the funding source are displayed with some indication that choosing the wrong funding sourced product is discouraged (e.g., hover over tooltip, color, bolding, graying out, or other UI indication used by the SUT for similar issues)
• Active: Selection of a specific privately funded vaccine product to administer generates informative messages in a method consistent with the SUT for similar issues) - Active informing

The SUT makes the mismatch of the vaccine product's funding source and the patient's vaccine program eligibility visually apparent to the administering practitioner or does not permit the administering practitioner from selecting the mismatched vaccine.

The SUT may meet the requirement by prohibiting the selection of mismatch. However, careful consideration should be made when implementing such a strategy. This may result in patients not being immunized in a timely manner.

The following information is a not evaluated portion of this test step but supports subsequent test steps and should be performed by the SUT user:

Alexandria Jacqueline Montoya (DOB 03/27/2012) is administered vaccines by Nurse Daniela Jennifer Wyatt who enters the following information into the SUT:

Product Name (This may vary with each implementation)	GARDASIL 9 00006-4121-01
Date Administered	Today's Date
Unit-of-Use (Syringe or Vial) NDC	00006-4121-01
Manufacturer	Merck and Co., Inc.
Lot Number	IIPVAXN08
Expiration Date	09/27/2029
Unit-of-Use (Vial/Syringe) Image that may be scanned.
GTIN 00300064121018
Patient Dose-level Eligibility for Vaccines for Children	VFC eligible - Medicaid/Medicaid Managed Care
Vaccine Funding Source	Private funds
Route	INTRAMUSCULAR
Site	Left Deltoid
VIS Given	HPV (Human Papillomavirus) Vaccine VIS - 08/06/2021
CVX	165
MVX	MSD
Funding Source Code	PHC70
Packaging	10 pack – 1 dose syringe
Trade Name	GARDASIL 9
Generic Name (CVX 165)	HPV9

The VIS encoded value that is associated with the most current VIS for the vaccines and evaluated in the transmit message, can be found in the CDC VIS Lookup Table located here: https://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html

Nurse Daniela Wyatt receives a secure message that indicates one of the clinic's patients was recently seen by an associated hospital emergency department due to an adverse reaction associated with a vaccine dose administered outside the patient's medical home.

On 12/22/2023 Selma Nadia McKay (DOB 02/05/2023) is vaccinated against Hepatitis A outside of her medical home (Oregon Family Medicine).

After receiving the vaccine, Selma experiences an anaphylactic reaction and paramedics transfer her to a hospital emergency department. She recovers and is discharged home.

Selma’s mother follows up with Selma’s primary care provider, providing the outside clinic vaccination record and the Emergency Department (ED) discharge documentation.  The SUT user records this historical vaccination in the SUT (during preload).

Daniela Jennifer Wyatt is the practitioner.

See test step for additional details.

See test step for additional details.

In scope: Enables local capture of structured data regarding vaccine-related adverse events. 

Not in scope: Transmission of adverse event data to the IIS is out of scope due to immaturity of standards and inconsistent willingness of IIS to receive information regarding adverse events. 

Not in scope: Reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS) is considered out of scope as it addresses a unique workflow initiated at the time a practitioner identifies and records a potential vaccine-associated adverse event. Such occurrence may be within minutes to days after transmission of vaccine administration data to the IIS. Further, a consensus-based interoperability standard is not evident to require consistent interoperability method for VAERS reporting.

Nurse Daniela Wyatt receives a secure message that indicates one of the clinic's patients was recently seen by an associated hospital emergency department due to an adverse reaction associated with a vaccine dose administered outside the patient's medical home.

On 12/22/2023 Selma Nadia McKay (DOB 02/05/2023) is vaccinated against Hepatitis A outside of her medical home (Oregon Family Medicine).

After receiving the vaccine, Selma experiences an anaphylactic reaction and paramedics transfer her to a hospital emergency department. She recovers and is discharged home.

Selma’s mother follows up with Selma’s primary care provider, providing the outside clinic vaccination record and the Emergency Department (ED) discharge documentation.  The SUT user records this historical vaccination in the SUT (during preload).

Supports 3.12.2 Enables local capture of structured data regarding adverse events.

The user selects Selma Nadia McKay (DOB 02/05/2023) as the patient and opens the patient's record in the SUT.

This step sets up the testing for recording historical vaccines and adverse events. No evaluation is required.

Selma Nadia McKay (DOB 02/05/2023) is registered in the SUT; including information about her primary medical home Oregon Family Medicine

Daniela Jennifer Wyatt is the practitioner.

Selma Nadia McKay (DOB 02/05/2023) is the active working patient in the SUT.

Go to step 3.12.2

The SUT is able to select a patient for the purpose of recording adverse event details in the patient's medical record.

This is a non-evaluated test step that must be performed to support other associated steps.

The following patient is selected as the active patient:

Nurse Daniela Wyatt receives a secure message that indicates one of the clinic's patients was recently seen by an associated hospital emergency department due to an adverse reaction associated with a vaccine dose administered outside the patient's medical home.

Selma Nadia McKay (DOB 02/05/2023) is registered in the SUT and one dose of Hep A ped/Adol has been recorded (in preload historical data.). Patient has received 1 of 2 doses.

Daniela Jennifer Wyatt is the practitioner.

A user has recorded and saved the adverse event for Selma Nadia McKay (DOB 02/05/2023) associated with one dose of Hep A, ped/adol, 2 dose (CVX 83) vaccine as structured data in the SUT. Patient received 1 of 2 doses.

Go to step 3.13.1

To test the capability that the SUT allows a user to record an adverse event with an established Vaccination Reaction and Adverse Event (IIS) code as structured data (not free text). See Note #1.

Due to the lack of maturity of standards and acceptance of adverse events, transmission to IIS is excluded from the IIP test plan.

The SUT interface allows the a user  to enter the minimum required data elements for recording an adverse event including causative agent, reaction date, adverse event (detail in "minimum required data elements")

The proctor will save screenshots of the user interface showing the required information. If the UI does not includes the structured data (e.g., CVX code and/or SNOMED Code) the proctor will request SUT display and obtain a screenshot of the underlying terminology mapping.

See test step for details.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

A practitioner at Oregon Family Medicine views the vaccine schedule for Selma Nadia McKay (DOB 02/05/2023) and orders the vaccine to be administered to the patient.

Selma Nadia McKay (DOB 02/05/2023) is registered in the SUT.

SUT includes an adverse event recorded for Selma Nadia McKay (DOB 02/05/2023) with causative agent = Hep A ped/adol, 2 dose (83) and reaction = anaphylaxis (SNOMED-CT 39579001) onset 03/22/2024.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

The order for Hep A ped/adol has been entered and within the ordering process (during or post-entry) the SUT provides clear evidence of the prior reaction.

Go to step 3.13.2

To test the capability that the SUT informs the user of the previous vaccine-related adverse reaction although the user overrides the information and enters the order (or the order generates an alert).

The ordering workflow includes clear evidence of a previous adverse reaction to Hepatitis A vaccine in at least one of the following ways (only 1 method is required):

• The vaccine schedule displays evidence of a concern regarding the display for Hepatitis A vaccine
• The display of orderable vaccines has an indication of a concern to address specific to the Hepatitis A vaccine options
• Selection of a specific Hepatitis A vaccine to order includes indication of a concern to move forward with the order
• Entry of the order for Hepatitis A vaccine results in a message indicating the previous adverse reaction
• The user is able to proceed with entering / completing / saving the order, thus bypassing the information provided.

In scope: Expect evidence of prior adverse event to be present in the user interface (actively or passively) at the time of vaccine selection, ordering, or administration.

Not in scope: Transmission of prior adverse event data to the IIS

A vaccine administering practitioner at Oregon Family Medicine attempts to administer Hepatitis A vaccine to Selma Nadia McKay (DOB 02/05/2023) based on the order previously entered.

·      Selma Nadia McKay (DOB 02/05/2023) is registered in the SUT
·      SUT includes an adverse event recorded for Selma Nadia McKay (DOB 02/05/2023) with causative agent = Hep A ped/adol, 2 dose (83) and reaction = anaphylaxis (SNOMED-CT 39579001) onset 12/22/2023
·      Hep A vaccine order exists (i.e., has been placed)
·      SUT provides a list of available vaccine product to fulfill the order for Hepatitis A vaccine

Daniela Jennifer Wyatt is the administering practitioner.

Selection for any Hep A ped/adol product provides evidence of the prior reaction and the administration is avoided.

Go to step 4.1.1

To test the capability that the SUT informs the individual administering a vaccine that the patient had an adverse reaction this vaccine in the past. The method and timing of notification can be specified to meet local clinical workflow. This requirement is a “failsafe” mechanism in case the practitioner orders a vaccine dose that may be unsafe for the patient.

The practitioner prepares to administer the Hepatitis A vaccine, and system informs the practitioner that the patient had an adverse reaction in the past. Successful performance requires:

The administration workflow includes clear evidence of a previous adverse reaction to Hepatitis A vaccine in at least one of the following ways (only 1 method is required):

* The SUT provides a "task" for the administering practitioner. The "task" indicates an order exists to administer Hepatitis A vaccine to this patient and includes indication about a previous adverse reaction within the task message. The practitioner user then selects the option to choose a product to administer.

* The order, when opened, shows evidence that a warning about a previous adverse reaction has been overridden

* The available vaccine products display evidence of a concern regarding each of the Hepatitis A vaccine products

* Selection of a specific Hepatitis A vaccine to administer includes indication of a concern to move forward with the administration

See test step for details.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

Supports Test Step 3.15.3-During a well child exam, Dr. Ramon Bradshaw recommends that Deborah Charlotte McKay receive a hepatitis A vaccine. Deborah's mother, Angeline McKay, disagrees with Dr. Ramon Bradshaw's recommendation due to Deborah's twin Selma having a previous adverse reaction to the vaccine and wants to make her refusal clear that Deborah Charlotte McKay is not to receive the vaccine today or in the future.

The user selects Deborah Charlotte McKay (DOB 02/05/2023) as the patient and opens the patient's record in the SUT.

Deborah Charlotte McKay (DOB 02/05/2023) is registered in the SUT.

Dr. Ramon Michael Bradshaw is the ordering practitioner.

Daniela Jennifer Wyatt is the entering practitioner for the order.

Deborah Charlotte McKay (DOB 02/05/2023) is the active patient in the SUT.

Go to step 3.14.2

The SUT selects a patient record to perform subsequent actions.

This is not an evaluated step that must be performed to support other associated steps.

The following patient is selected as the active patient:

This is not an evaluated step to start the "Care Provision and Documentation" capability.

Supports Test Step 3.15.3-During a well child exam, Dr. Ramon Bradshaw recommends that Deborah McKay receive a hepatitis A vaccine. Prior to the exam, Dr. Bradshaw reviews the patient's medical record and preps the record by entering the recommended vaccine orders in the encounter.

Dr. Bradshaw has ordered a dose of hepatitis A vaccine and a dose of hepatitis B vaccine.

Daniela Jennifer Wyatt is the entering practitioner for the order.

The Hep A order is visible to the administering practitioner.

The Hep B order is visible to the administering practitioner.

Go to step 3.14.3

The SUT allows the order of a vaccine.

This is not an evaluated step that must be performed to support other associated steps.

This is non evaluated step to the "Care Provision and Documentation" capability.

The following vaccine order is entered prior to the parent refusal:

The following vaccine order is entered:

During a well child exam, Dr. Ramon Bradshaw recommends that Deborah Charlotte McKay receive a hepatitis A vaccine. Deborah's mother, Angeline McKay, disagrees with Dr. Ramon Bradshaw's recommendation and wants to make her refusal clear that Deborah Charlotte McKay is not to recieve the vaccine today or in the future.

Practitioner pre records the vaccine administration prior to giving the vaccine and patient's mother refusing. The vaccine is transmitted but later deleted (step 5.5.3) and refusal sent  (step 5.5.5).

Deborah McKay exists in the SUT.

Daniela Jennifer Wyatt is the administering practitioner.

The vaccine record is available to SUT users.

Go to step 5.5.1 to transmit the vaccine recorded in this step.

This test step sets up future flow for transmission to the IIS supporting the ability to delete a record. It is not evaluated

This is not an evaluated step that must be performed to support other associated steps.

User shall record the vaccine for hepatitis A in the SUT with the following data:
Product Name (This may vary with each implementation)	HAVRIX 58160-0825-43
Date Administered	Today's date
Unit-of-Use (Syringe or Vial) NDC	58160-0825-43 GTIN 10358160825436
Manufacturer Name	GlaxoSmithKline
Lot Number	IIPVAXN11
Expiration Date	09/27/2029
MVX (Manufacturer Code)	SKB
CVX	83
Patient Dose-level Eligibility for Vaccines for Children	Not VFC Eligible
Vaccine Funding Source	Private funds
Route	INTRAMUSCULAR
Site	Left Vastus Lateralis
VIS Given	Hepatitis A Vaccine VIS - 10/15/2021

The VIS encoded value that is associated with the most current VIS for the vaccines and evaluated in the transmit message, can be found in the CDC VIS Lookup Table located here: https://www.cdc.gov/vaccines/programs/iis/code-sets/vis-barcode-lookup-table.html

During a well child exam, Dr. Ramon Bradshaw recommends that Deborah Charlotte McKay receive a hepatitis A vaccine. Deborah's mother, Angeline McKay, disagrees with Dr. Ramon Bradshaw's recommendation and wants to make her refusal clear that Deborah Charlotte McKay is not to receive the vaccine today or in the future.

Deborah McKay exists in the SUT.

Daniela Jennifer Wyatt is the practitioner recording refusal.

The Hep B order is visible to the administering practitioner.

The refusal record is available to SUT users.

The Hep B administration is visible to SUT users.

Go to step 5.6.1 to transmit refusal from this step.

To test the capability that the SUT allows users to record vaccine administration refusal by a patient or caregiver.

The coded values are not expected to be displayed to the user, but it is expected that the value selected has the identified meaning, and it is expected that the system will use the coded value when the attribute is conveyed in later transactions.

Vaccine 2 Administration -The 2D Barcode provided information in the following fields should be correct and without omission.
Product Name (This may vary with each implementation)	ENGERIX-B 58160-0820-43
Date Administered	Today's date
Unit-of-Use (Syringe or Vial) NDC	58160-820-43 (for reference only, please scan 2D barcode)
Manufacturer	GlaxoSmithKline (for reference only, please scan 2D barcode)
Lot Number	IIPVAXN04 (for reference only, please scan 2D barcode)
Expiration Date	09/27/2029 (for reference only, please scan 2D barcode)
CVX 08	08
Unit-of-Use (Vial/Syringe) Image that shall be scanned.
GTIN 10358160811439
Dose-level Eligibility for Vaccines for Children	Not VFC eligible
Route	INTRAMUSCULAR
Site	Right Vastus Lateralis
VIS Given	Hepatitis B Vaccine VIS - 05/12/2023

User shall record the refusal for hepatitis A in the SUT with the following data: Substance/Treatment Refusal Reason: Parent Decision (NIP002 00);

The UI may not show the codes referenced but the SUT SHALL show there is underlying code to support transmission to the IIS as coded data with the RXA Completion status of Refused (RE)

See test step for details.

The SUT provides customers with the ability to list a cohort of all patients who are (a) due for vaccines, (b) overdue for vaccines, and (c) recipients of specific vaccine lot numbers.

The ability to create cohort reports based upon specific filtering parameters

This is a non-evaluated test step that must be performed to support other associated steps.

This was an attestation item-previously attested to.

The SUT allows for the query of a patient's evaluated immunization history and vaccine forecast. SUT receives various responses to a query of a patient's evaluated immunization history and vaccine forecast from IIS. SUT allows for the reconciliation of immunization data received from IIS.

A Z44 profile message (query) is generated and transmitted to the IIS and a Z42 response is returned.

See test steps for details

SUT Proctor takes a screenshot of the SUT's local forecast before performing query for evaluated history and forecast. This is to support Step 4.5.1 - re-evaluate patient's immunization forecast after reconciling IIS-provided vaccine history.

The user selects Deborah Charlotte McKay (DOB 02/05/2023) as the patient and opens the patient's record in the SUT.

Existing patient's demographic data are stored within the SUT.

Selma Nadia McKay (DOB 02/05/2023), has the following vaccines recorded in the SUT: 1 dose of Hepatitis A and 1 dose of Hepatitis B and has the following vaccines recorded in the IIS: 3 doses of Hepatitis B, 3 doses of Rotavirus, 3 doses of DTaP, 4 doses of Hib, 4 doses of PCV20, 3 dose of IPV, 2 doses influenza, 2 MMR (1 invalid, 1 as MMRV-Varicella.)

The patient has the following vaccines recorded in the SUT: 1 dose of Hepatitis A and 1 dose of Hepatitis B.

Daniela Jennifer Wyatt is the practitioner.

See test step

Not evaluated

The Rotavirus vaccine should not appear in the forecast for children older than 15 weeks who have not been immunized.

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

The SUT forecast for Selma Nadia McKay (DOB 02/05/2023) is being displayed. A patient's immunization history in the SUT is incomplete. A query for an immunization history and forecast to the IIS and processing a response have not yet been performed. The incomplete nature of the patient's immunization history also impacts the SUT's forecast. The SUT is likely recommending vaccine doses that have been administered yet are not known to the SUT. Since the SUT has not yet queried the IIS for the patients vaccination history, the local vaccination history is incomplete and the forecast is based upon the same incomplete information.

Selma Nadia McKay (DOB 02/05/2023), has the following vaccines recorded in the SUT: 1 dose of Hepatitis A and 1 dose of Hepatitis B and has the following vaccines recorded in the IIS: 3 doses of Hepatitis B, 3 doses of Rotavirus, 3 doses of DTaP, 4 doses of Hib, 4 doses of PCV20, 3 dose of IPV, 2 doses influenza, 2 MMR (1 invalid, 1 as MMRV (Varicella.)

Daniela Jennifer Wyatt is the practitioner.

The patient's vaccine forecast from the SUT is available to a practitioner.

Go to step 4.2.1

The ability of the SUT to display an updated forecast post-reconciliation of the immunization history.

While the proctor is not evaluating the content of the forecast in this step, the proctor is asked to take a screenshot to compare this forecast with the future forecast in step 4.5.1. The screenshot should include the vaccines listed. This is to support Step 4.5.1 - re-evaluate patient's immunization forecast after reconciling IIS-provided vaccine history.

Due to the limited vaccination records within the SUT the following vaccines are provided to SUT users:

The Rotavirus vaccine should not appear in the forecast for children older than 15 weeks who have not been immunized.

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

SUT Requests (query) a patient's evaluated immunization history and vaccine forecast from an IIS using an HL7 v2.5.1 Z44 profile message.

Existing patient's demographic data are stored within the SUT.

Selma Nadia McKay (DOB 02/05/2023), has the following vaccines recorded in the SUT: 1 dose of Hepatitis A and 1 dose of Hepatitis B and has the following vaccines recorded in the IIS: 3 doses of Hepatitis B, 3 doses of Rotavirus, 3 doses of DTaP, 4 doses of Hib, 4 doses of PCV20, 3 dose of IPV, 2 doses influenza, 2 MMR (1 invalid, 1 as MMRV (Varicella.)

Daniela Jennifer Wyatt is the practitioner.

The Rotavirus vaccine should not appear in the forecast for children older than 15 weeks who have not been immunized.

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

SUT shall Requests (query) a patient's evaluated immunization history and vaccine forecast from an IIS using an HL7 v2.5.1 Z44 profile message.

Nurse, Daniela Wyatt, uses SUT to lookup (query) Selma Nadia McKay evaluated immunization history and forecast.

Selma Nadia McKay's demographic data are stored within the SUT.

Some of Selma Nadia McKay's immunization data from the IIS does not exist within the SUT.

Selma Nadia McKay's evaluated immunization history and forecast exists within the IIS.

Daniela Jennifer Wyatt is the practitioner.

A query for Selma Nadia McKay's evaluated immunization history and forecast (profile Z44 message) has been sent from the SUT to the IIS.

Go to step 4.2.2 to receive and process RSP from this step

To test the capability that the SUT is able to query patient immunization history and forecast from IIS.

SUT triggers Z-44 profile message (request for evaluated history and forecast) to the IIS that meets the following requirements:

The message's Query by Parameter (QDP) segment contains the following patient information:

- Limits the query response to one response (RCP-2.1 = 1)

The Rotavirus vaccine should not appear in the forecast for children older than 15 weeks who have not been immunized.

RSV is not included in this test plan forecast but may be included in your results-not evaluated.

After receiving a query for the patient's evaluated history and forecast, the IIS generates and sends a return evaluated history response (RSP -- Z42 profile) message to the SUT.

A query for Selma Nadia McKay's evaluated immunization history and forecast (profile Z44 message) has been sent from the SUT to the IIS.

Selma Nadia McKay (DOB 02/05/2023), has the following vaccines recorded in the SUT: 1 dose of Hepatitis A and 1 dose of Hepatitis B and has the following vaccines recorded in the IIS: 3 doses of Hepatitis B, 3 doses of Rotavirus, 3 doses of DTaP, 4 doses of Hib, 4 doses of PCV20, 3 dose of IPV, 2 doses influenza, 2 MMR (1 invalid, 1 as MMRV (Varicella.)

Daniela Jennifer Wyatt is the practitioner.

The patient's evaluated immunization history from the IIS is available to a clinician to compare with the SUT's records.

Go to step 4.3.1

Confirms valid receipt and display of response message using the Juror Document.
To test the capability that the SUT is able to consume immunization history returned from IIS.

Confirm SUT's receipt of a return evaluated history (RSP -- Z42 Profile) message from an IIS that includes the following history details (IIS forecast does not need to be displayed). Validity must be present but validity reason may or may not be present and will not be evaluated.